European Alzheimer's experts unconvinced by new Eisai, Biogen drug

[June 13, 2023]  By Natalie Grover

LONDON (Reuters) - Alzheimer's disease experts in Europe weighing potential use of a new drug from Eisai and Biogen say its ability to slow cognitive decline may not outweigh its health risks, or be worth the toll on scarce healthcare resources.

Lecanemab, branded Leqembi in the U.S., is under regulatory review in Europe and likely poised for traditional U.S. approval next month based on trial data showing it slowed cognitive decline by 27% in patients with early Alzheimer's.

In Europe, where cost-conscious countries rigorously weigh new drugs before adopting their use, nine neurologists and researchers across six countries told Reuters lecanemab is unlikely to be widely used if approved. Their views underpin analyst estimates suggesting Europe will be a small market for the drug.

Some doctors said its effect on the disease may not be clinically meaningful enough when weighed against the risk of brain swelling, its likely high price, and limited personnel and resources to administer twice monthly infusions and monitor for brain swelling with MRI scans.

Lecanemab works by removing sticky clumps of the protein amyloid beta from the brain believed to be a hallmark of Alzheimer's. Nearly 13% of patients treated with the drug in the trial experienced potentially serious brain swelling.

Dr. Carlo Colosimo, chairman of the department of neurology at Santa Maria University Hospital in Italy, said patients desperate for anything that can alter their disease course are already enquiring about lecanemab.

"But we have to consider the overall picture, and I can say for the majority of the experts in my country, it is not worthwhile," he said.

An Eisai spokesperson noted significant health system challenges associated with adopting a new treatment for early Alzheimer’s, but expressed confidence they could be overcome. Eisai said it could not comment on perspectives of clinicians.

There are an estimated 7 million people in Europe with Alzheimer’s, a number expected to double by 2030, according to the European Brain Council.

Colosimo, a member of a ten-person independent panel that sometimes advises Europe’s drug regulator on neurology treatments, said he doubted lecanemab would be clinically meaningful for patients.

While these trial results were statistically significant, it would not be surprising if the European regulator rejects the drug, he said.

The European Medicines Agency (EMA) reviewing lecanemab is expected to weigh in late this year or early 2024 but declined to comment on its process. Still, if approved and launched, doctors said the drug will prime European healthcare systems for more effective treatments to come.

'IS THAT ALL'

Analysts expect EMA to approve the drug and for it to be used in Europe next year, but see the U.S. accounting for the majority of sales.

Barclays analysts have forecast Europe sales will pick up pace overtime and peak in 2032 at about 13% of the patient population. It forecast sales of $2.6 billion in Europe versus $3.7 billion in the U.S. that year.

A scientist looks at hypometabolic and hypoperfusion patterns at the single-subject level from a patient suffering from Alzheimer's disease at the Memory Centre at the Department of Readaptation and Geriatrics of the University Hospital (HUG), in Geneva, Switzerland, June 6, 2023. REUTERS/Denis Balibouse

Widespread media coverage of lecanemab's clinical trial success has led patients to believe it's a cure-all, researchers said.

“That would be too much of an expectation," said Professor Frank Jessen, main author of the German national guideline on diagnosis and treatment of dementia. "What it does is it slows the progression. For patients to understand this is not easy."

A 18-point scale used in the trial to measure functions such as memory and problem solving showed only a small absolute difference in patients who received lecanemab versus those who got a placebo.

Professor Giovanni Frisoni, director of a memory clinic in Geneva that sees about 900 patients a year, suggested the drug's impact would likely underwhelm patients.

"We scream with joy as clinicians who have been working for 30 years to see the first (effective) drug, but if you're a patient… you say, 'okay, is that all?'"

MOUNTING COSTS

Currently, most care for Alzheimer’s is focused on managing symptoms such as memory and cognition decline.

The World Health Organization (WHO) estimated the cost in Europe of caring for people with dementia, including Alzheimer's, at $439 billion, or $31,144 per person in 2019. That includes hospital care, medicines, diagnostics, informal caregiver time, community services and long-term care facility costs.

Use of lecanemab could add to that. It lists for $26,500 a year in the U.S., though most countries in Europe will likely negotiate a lower price.

Diagnostic equipment and staff would be needed to screen for eligible patients through lumbar punctures for cerebrospinal fluid (CSF) analysis or PET brain scans to detect the presence of amyloid in the brain.

A 2019 study estimated first-year costs for 100,000 CSF tests would be 63.3 million pounds ($79.6 million), including the cost of specialist training for UK nurses.

Specialised infusion nurses and trained personnel to evaluate MRI scans for brain swelling would be needed.

Healthcare resources are already short across Europe, according to the WHO. In Italy, there is an estimated shortage of 29,000 healthcare professionals in hospitals, a national study found.

"Is this (drug) really what we should invest in our overburdened healthcare systems?" said Dr. Edo Richard, professor of neurology at Radboud University Medical Centre in the Netherlands. "I think it's not realistic. And it's not something we should try for."

(Reporting by Natalie Grover in London; Additional reporting by Emilio Parodi in Milan; Editing by Caroline Humer and Bill Berkrot)

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